Licensing and Registration of Food Establishments

Legal basis, governing authorities

Republic Act No. 10611 establishes the Food Safety Act of 2013 and mandates the Department of Health (DOH) through the Food and Drug Administration (FDA) to ensure safety of food processing and product packaging activities.
Republic Act No. 9711 directs the FDA through the Center for Food Regulation and Research (CFRR) to protect and promote the right to health and to implement a performance-based food safety control management system.
The administrative system uses risk-based food control strategies, including enforcement of HACCP and other risk-based control measures, and supports post-market monitoring.
Book I, Article VIII of the IRR of RA 9711 under Section 7 (g) is referenced for decision authority in licensing disapprovals in the evaluation process.

Policy, purpose, risk-based control

The Order adopts a risk-based approach for product and establishment risk categorization, focusing on preventive rather than corrective strategies.
The FDA shall ensure food safety through food quality standards in the country and through licensing and product registration authorizations.
The Order establishes authorization instruments that include permit, license, certificate of registration, certificate of compliance, and exemption (or similar documents).
High-risk food establishments shall be priority for inspection under the FDA’s risk-based approach (Annex A is referenced for risk classification and prioritization).

Coverage and key definitions

The Order covers food establishments engaged in manufacture and/or distribution (including import, export and/or wholesale) and trade and/or repacking of processed food and food products.
The Order does not cover fresh or raw food derived from plant, animal, fisheries and aquaculture products or foods in the primary production and post-harvest stages of the supply chain under the Department of Agriculture.
The Order does not cover food businesses under the purview of Local Government Units (LGUs), including slaughter-houses, poultry dressing plants, fish ports, wet markets, supermarkets, school canteens, restaurants, catering establishments, water refilling stations, street food sale, including ambulant vending.
The Order defines Authorization as permission embodied in a document granted by a regulatory agency to a natural or juridical person for food business operation, which can take forms such as permit, license, certificate of registration, certificate of compliance, certificate of exemption, or similar documents.
The Order defines License to Operate (LTO) as the authorization required before engaging in covered food business activities.
The Order defines Certificate of Product Registration (CPR) as an authorization issued by the FDA for specific health products after evaluation and approval of submitted registration requirements.
The Order defines Bottled Water as water placed in a sealed container offered for sale for human consumption as drinking water.
The Order defines operational and technical terms including: Activity, Advertising, Contaminant, Control measure, Distribute/Distribution/Distributor/Wholesaler, Establishment, Export/Import/Wholesale/Retailer, Food, Food Additive, Food-home illnesses, Food Business, Food Business Operator, Food/Dietary Supplement, Fortification, GMP, GDP/GSP, HACCP, Inspection, Label, Licensing, LGU, Manufacturer, Monitoring, Packaging, Packer, Permit, Processing, Repackaging/Repacker, Risk, Salt Iodization, Source, Trader, Toll Manufacturer, and related defined terms used throughout the licensing and registration rules.

Licensing of food establishments (LTO)

All food establishments must secure an LTO before engaging in food manufacturing, importation, exportation, sale, offer for sale, distribution, transfer, and where applicable use, testing, promotion, advertisement, and/or sponsorship of food products (General Principles).
Food establishments are authorized through risk categorization, and FDA issues authorization based on risk categorization; high-risk establishments are prioritized for inspection (Annex A).
Applications for LTO are accepted by the FDA only when all requirements have been completed (General Principles).
Applicants must secure LTO first through an initial application, and after securing LTO, must file the CPR initial application (General Principles).
An LTO is a requirement before a food establishment can join food trade and exhibitions, perform market research, or test unregistered processed food products (General Principles).
Only the FDA issues licensing when establishments demonstrate consistency in manufacture and/or distribution of safe and quality products (General Principles).
At a given address/facility, only one licensed establishment should operate, and establishments engaged in the same activity may not share the same address or facility regardless of ownership (General Principles).
A valid LTO must be displayed in a conspicuous place in the establishment or business office/premises; failure to display is ground for revocation of the LTO (General Principles).
No initial or renewal application for LTO is accepted or approved unless the prescribed fee is paid (General Principles).
For changes in business information, previously approved circumstances (including location, business name and owner, additional or reduction in the product lines, inclusion or deletion of any activities/products) must be effected only with prior notification to the FDA through amendment (General Principles).
For assignment or transfer of pending applications or existing licenses where there is change in ownership while application is on process, the application is considered terminated and documents are returned to the authorized representative; the new owner/new regulatory officer must comply with initial application requirements, including attendance to QPIRA (General Principles).
Licensed establishments with revoked/cancelled/suspended LTO resulting from violations under this Order and/or RA 9711 and/or other relevant food regulations, after due process, may not re-apply for a new LTO for three (3) years and may not use the same business name (General Principles).
FDA-licensed establishments and operators must comply with laws addressing nutritional quality, including RA 8172 (ASIN Law) and RA 8976 (Food Fortification Act), and must comply with RA No. 9711, RA No. 10611, RA No. 3720 as amended by E.O. 175, RA No. 7394, and Presidential Decree No. 856 (General Principles).
Licensing allowed activities are governed by the single-license hierarchy: a manufacturer may engage in any activity it can satisfy (including processing); a packer/repacker may engage in any activity it can satisfy except processing; a trader may engage in any activity it can satisfy except processing or packaging; a distributor is not allowed to engage in processing and/or packaging; distributor activities may be added by amendment; and multiple facilities within the same address engaged in different activities for the manufacture/distribution of a single product may be associated to a single license (General Principles, with Annex B referenced).

Specific LTO rules and process

A food manufacturing or processing plant is covered by a single LTO notwithstanding distance or different locations within one locality/municipality/city but with one product; the principal office address must appear on the front page, and other addresses on the back page or secondary page appended (Specific Guidelines for Manufacturers including Traders).
If a manufacturing plant has entirely different and complete stages of operation for different products in different locations within one municipality/city, then each stage must be covered by separate licenses (Specific Guidelines for Manufacturers including Traders).
Food manufacturing establishments that use or share one facility are not allowed regardless of ownership (Specific Guidelines for Manufacturers including Traders).
FDA-licensed food manufacturers may import raw materials or finished products as ingredients or additives for their own use to manufacture registered food products; raw materials covered by RA 8976 and related issuances must comply with importation requirements such as results of analysis and/or inspection (Specific Guidelines for Manufacturers including Traders).
For bottled drinking water, standards and GMP requirements under Administrative Order No. 18-A s. 1993 or the Philippine National Standard for Bottled Drinking Water and their amended versions must be followed (Specific Guidelines for Manufacturers including Traders).
For distributor offices of importers/exporters/wholesalers, all warehouses and depots must be declared, and sharing of offices by different distributors is not allowed (Specific Guidelines for Distributor).
An establishment applying for a license as a food distributor that uses or shares one office with another establishment is not allowed regardless of ownership (Specific Guidelines for Distributor).
An LTO as distributor/importer/exporter/wholesaler permits manufacturing or repacking only if a separate LTO as manufacturer/repacker is secured; the additional activity requirements must be submitted to FDA (Specific Guidelines for Distributor).
FDA licensing authorizes disapproval through a formal process: the FDA issues a Certificate of Compliance by the inspectorate in the respective regions, and pre-licensing inspections (when required) must be scheduled with the applicant before the Certificate of Compliance is issued (Process of Application).
Approval or disapproval signed on COCs is performed by the Director, CFRR under the authority of the FDA Director General (Process of Application).
If evaluation, monitoring, inspection, or spot checking reveals violations, a report may serve as basis for motu proprio action by the Director of the Regional Field Office, and the RFO upon verification/inspection that the food establishment has not complied has the power to disapprove and sign the proper action by the Director of the RFO (Process of Application).
Notices of disapproval of applications for license must clearly state the reason for disapproval (Process of Application).
LTO validity: Initial LTO is valid for two (2) years; renewed LTO is valid for five (5) years (Validity of the LTO).
Requirements and amendments are governed by Annex C; fees are collected under existing rules on fees and charges or surcharges (Requirements, Fees and Other Charges).

Grounds for disapproval and licensing actions

Applications must be disapproved if the applicant fails to submit complete documentary requirements or fails to correct them (Section VIII).
Applications must be disapproved if the applicant fails to meet the appropriate standard or requirement evaluation of documents or fails in inspection evaluation of the food establishment’s offices and premises (Section VIII).
Applications must be disapproved if the applicant fails to respond to a notice of deficiency or fails to submit required documents on time (Section VIII).
Applications must be disapproved if there are misrepresentations, false entries, or withheld relevant data contrary to the provisions of the law, this Order, or appropriate standards (Section VIII).
The FDA may disapprove on analogous grounds or causes determined by the FDA (Section VIII).

Product registration (CPR) and product claims

Processed food products including food additives, food supplements, and bottled water must be registered with the FDA first before they are distributed, supplied, sold or offered for sale or use, and advertised, among other marketing/promotional activities (General Principles under CPR).
Only one (1) CPR is issued to a product with multiple packaging sizes if it has: the same brand name, same product name/variant, same product formulation/ingredients in the same order of proportion, and same label information except net weight.
Only one (1) CPR is issued to a product with multiple artwork designs and/or multiple suggested recipes if it has: the same brand name, same product name/variant, same product formulation/ingredients in the same order of proportion, and same label information except net weight.
Additional label design or other label changes must be secured by the company through permission from FDA through notification prior to use in advertisement, promotion, and commercial distribution.
If a product fails to meet registration requirements, applicable product standards, and labeling regulations, FDA issues a Letter of Denial and gives the applicant a maximum of six (6) months to comply and file for re-application (CPR General Principles).
Imported and locally manufactured raw materials, ingredients, and food additives intended to be sold, offered for sale or use, or distributed to other food establishments and food business operators and consumers must secure a CPR for each by the importer or distributor.
Local food manufacturers that directly import and use raw materials/ingredients/food additives for their own use or for further processing to manufacture a processed food product need not secure a CPR for the raw materials/ingredients/food additives (CPR General Principles).
When a CPR is granted to a food manufacturer/importer, all individual ingredients in the FDA-registered formulation may be imported without a CPR, but the FDA-licensed manufacturer/importer must purchase local ingredients and food additives only from FDA-licensed establishments.
Export-focused registrations follow the same registration requirements; exporters must comply with standards and requirements of the importing country, including labeling requirements.
A product previously registered for local distribution may be exported using the same CPR if labeling and importing-country standards are met, and conditions include: same brand name, same product name/variant, same product formulation/ingredients in the same order of proportion, and same label information except net weight, with notification to FDA and submission of labels in the importing country’s language.
Food additives eligible for CPR are limited to those listed in the latest Codex General Standards for Food Additives (GSFA) and/or the latest FDA Listing of Food Additives and/or approved pharmaceutical excipients list intended for food supplement in pharmaceutical dosage forms such as tablet, soft gel capsule and capsule.
CPR validity: The CPR is valid for 2 years minimum to 5 years maximum for initial issuance and 5 years for renewal; renewal requires continued conformity with pertinent standards and requirements including labeling regulations.
The FDA may require additional documents for high-risk foods when necessary to address uncertainties on safety through a separate issuance; high-risk products include infant formula, milk supplements, foods for infants and young children, foods for special medical purposes, and foods for special dietary uses.
The FDA may impose other requirements by regulatory issuance in case of health issues other than growth of pathogenic microorganisms or other food safety incidents, such as chemical contamination or adulteration.
The FDA may conduct inspection of the manufacturing/processing plant or verify submitted documents, or require additional documents or evidence to ascertain safety and/or quality of the product.
Food products are evaluated based on the technical documents submitted for safety and quality; only products that comply with requirements and meet standards for food safety, quality, and labeling—consistent with relevant FDA/Codex standards for specific categories—receive a CPR (Quality and Safety Standard).
Food establishments and operators must conform to General Principles of Food Hygiene and, as appropriate, comply with standards and requirements on GMP, HACCP, Good Storage Practice, Good Distribution Practice, and Sanitary Standard Operating Procedures.
Food establishments must comply with the requirements of the ASIN Law and Food Fortification Law and related issuances and other food quality and safety standards adopted or determined by FDA.
Products covered by separate laws requiring submission of Certificate of Analysis (COA) must comply with those COA submission requirements.
No food samples may be submitted to FDA when labels are clear and bear complete label information, but food supplements must submit product samples in commercial presentation.
Food supplements must not have curative claims or therapeutic claims, and other claims must follow existing relevant labeling guidelines.
Advertising and promotional materials may not make curative or therapeutic claims without scientific data or clinical trials to substantiate such claims.
CPR issuance is governed by Annex D for requirements and amendments.
The Director General of the FDA, upon recommendation of the Center Director for Food, promulgates procedural rules on registration; issuance of CPR is based on compliance with applicable standards and requirements.
If a product does not conform with applicable standards/requirements/regulations, FDA issues a Letter of Denial, gives 6 months to reapply by submitting deficiencies and the complete set of documents; otherwise the application is considered as an initial application.

Inspection, compliance certificates, and enforcement

The FDA/CHD verifies submitted documents and conducts inspection prior to licensing depending on the safety risk of products handled by the establishment.
FDA may conduct inspection in collaboration with LGUs and any agency/office under DOH, DA, and DILG.
Pre-licensing inspection and issuance of a Certificate of Compliance (COC) must follow a risk-based approach and may be aligned to HACCP/GMP requirements depending on risks and production complexity; inspection must be covered by a Quality Manual.
In lieu of a COC for the microenterprise food manufacturer, the FDA may accept the Sanitary Permit (establishment) and Health Certificate (food handlers) issued after inspection/examination by LGU sanitary inspectors or health facilities, as appropriate.
FDA may inspect at any time for routine spot checks, post-market surveillance, or to act on FDA reports of food-borne illness or complaints.
Upon validation of non-compliance to FDA safety and quality standards, the CFRR Director revokes LTO and CPR immediately, following due process.

Post-market surveillance, monitoring, and transition

Post-market surveillance and product monitoring must be conducted by FDA based on risks presented by food products.
FDA collects samples for testing and conducts routine and spot checking of establishments/operators.
FDA studies food-borne illnesses and epidemiological data as a basis for planning or instituting measures to reduce food-borne outbreaks.
Risk communication must be heightened in collaboration with stakeholders to reduce risks of food-borne illnesses brought about by food products.
Food establishments or operators must have a risk management plan or food safety plan and must attend food safety seminars or training to ensure continuous compliance.
Within six (6) months after the signing of the Order, FDA must streamline the national process and system of licensing and registration with other government agencies to increase protection of health and welfare of consumers and to ensure availability of processed food and food products in the market.

Administrative fees, separability, and repeals

Initial and renewal application fees and other charges are collected as allowed by existing rules on fees and charges or surcharges (Fees and Other Charges).
Separability clause: If any part or term is declared invalid or unenforceable, the remaining provisions remain valid and enforceable, and the Order is construed as if it did not contain the invalid part (Section XII).
Repealing clause: Administrative issuances, bureau circulars and memoranda, and other regulations inconsistent with the Order are withdrawn, repealed, and revoked accordingly (Section XIII).